A Study to Assess Adverse Events and How Oral ABBV-932 Moves Through the Body When Given With Oral Itraconazole in Adult Participants With Bipolar Disorder

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAbbVie

About this trial

This study will assess the adverse events and how oral ABBV-932 moves through the body when given with oral Itraconazole in adult participants with bipolar disorder.

Eligibility criteria

Qualifiers

Body Mass Index (BMI) ≥ 18.0 to ≤ 38.0 kg/m² after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.

A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) primary diagnosis of bipolar I or II disorder as confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0.2).

Disqualifiers

Clinical Global Impression-Severity (CGI-S) > 4 at Screening or Baseline.

History of psychiatric hospitalization (inpatient or intensive outpatient) in the past 3 months prior to screening.

Major depressive or manic episode within the past 3 months prior to screening.

Lifetime history of schizophrenia spectrum or other psychotic disorders, dissociative disorders, or neurocognitive disorders.

Trial design

Treatments tested in this trial

  • ABBV-932
  • Itraconazole

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators